FDA Final Rule on Laboratory Developed Tests (LDTs): Compliance Requirements and Deadlines

The FDA's Final Rule on Laboratory Developed Tests (LDTs), effective May 6, 2024, introduces a phased approach to regulating LDTs as medical devices. This initiative aims to ensure the safety and effectiveness of LDTs through increased oversight. Below is a comprehensive overview of the new requirements, associated deadlines, and resources to assist laboratories in achieving compliance.

As always, also follow the guidelines from your accreditation agency with any inspection requirements. This article was my attempt at learning more about the requirements and is just some suggestions with key deadlines and forms. They have also included FDA approved lab tests that are modified, check out the FAQ section here: https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/definitions-and-general-oversight-laboratory-developed-tests-faqs

Here's the FDA's answer regarding modified tests:

"When a laboratory modifies another manufacturer’s IVD, for example, by changing the intended use or the operating principles of the IVD, the laboratory has manufactured a new IVD and is the manufacturer of that IVD."

Please comment with any insights if you have gone through the process regarding the final rule on LDTs from the FDA.

Phaseout Timeline and Requirements

The FDA has outlined a four-year, five-stage phaseout policy to transition LDTs under its regulatory oversight:

Stage 1: May 6, 2025

·       Medical Device Reporting (MDR): Laboratories must establish procedures for tracking and reporting adverse events associated with their LDTs, in compliance with 21 CFR Part 803 [1].

·       Corrections and Removals Reporting: Implement processes to report any corrections or removals of LDTs, as specified in 21 CFR Part 806 [1].

·       Complaint Files: Maintain comprehensive records of customer complaints related to LDTs, adhering to 21 CFR § 820.198 [2].

Stage 2: May 6, 2026

·       Registration and Listing: Register the laboratory and list all LDTs with the FDA, providing detailed information about each test [1].

·       Labeling Compliance: Ensure that all LDTs meet labeling requirements as outlined in 21 CFR § 809.10(b), including necessary information in accompanying documentation such as package inserts [3].

·       Investigational Use Compliance: Adhere to regulations concerning the investigational use of LDTs [1].

Stage 3: May 6, 2027

·       Quality System (QS) Requirements: Comply with the broader QS regulations under 21 CFR Part 820, ensuring robust quality management practices are in place [1].

Stage 4: November 6, 2027

·       Premarket Review for High-Risk LDTs: Submit premarket approval applications for high-risk (Class III) LDTs. If a submission is under FDA review by this date, enforcement discretion may be exercised during the review period [1].

Stage 5: May 6, 2028

·       Premarket Review for Moderate and Low-Risk LDTs: Submit premarket notifications (510(k)s) for moderate-risk (Class II) and certain low-risk (Class I) LDTs requiring premarket submissions. Similar enforcement discretion applies if submissions are under review [1].

Compliance Checklist

To facilitate adherence to the FDA's Final Rule, laboratories should consider the following steps:

·       Establish Adverse Event Reporting Procedures: Develop and implement protocols for identifying, documenting, and reporting adverse events related to LDTs.

·       Implement Correction and Removal Processes: Create procedures to address and report any necessary corrections or removals of LDTs from the market.

·       Maintain Detailed Complaint Files: Set up a system for logging and investigating customer complaints concerning LDTs.

·       Prepare for Registration and Listing: Gather required information and complete the FDA's registration and listing process for the laboratory and its LDTs.

·       Review and Update Labeling: Ensure all LDTs have labeling that complies with FDA standards, including comprehensive package inserts.

·       Align with Investigational Use Regulations: If applicable, verify that investigational LDTs meet FDA requirements.

·       Develop a Quality Management System: Establish a quality system that complies with FDA regulations to ensure consistent test performance and reliability.

·       Plan for Premarket Submissions: Identify LDTs requiring premarket review and prepare the necessary documentation for submission to the FDA.

Resources and Forms

The FDA provides various resources to assist laboratories in achieving compliance:

·       Medical Device Reporting (MDR) Information and Forms: Guidance on MDR requirements and access to necessary reporting forms [4].

·       Device Registration and Listing: Instructions and forms for registering the laboratory and listing LDTs with the FDA [4].

·       Labeling Requirements: Detailed information on labeling standards for in vitro diagnostic devices [3].

·       Quality System Regulation Guidance: Resources to help develop and implement a compliant quality management system [4].

·       Premarket Submission Guidelines: Information on preparing and submitting premarket approval applications or notifications [4].

Example Documentation

To illustrate compliance, consider the following examples:

·       Adverse Event Reporting Procedure: A document outlining the steps for identifying, documenting, and reporting adverse events, including responsible personnel and timelines.

·       Complaint Handling Policy: A comprehensive policy detailing how customer complaints are received, documented, investigated, and resolved.

·       Quality Manual: A manual describing the laboratory's quality management system, including organizational structure, responsibilities, procedures, and processes to ensure compliance with FDA regulations.

By proactively addressing these requirements and utilizing available resources, laboratories can navigate the transition effectively, ensuring continued delivery of safe and reliable LDTs.

References

1.     FDA. (2024). FDA Final Rule on Laboratory Developed Tests (LDTs). Retrieved from https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests

2.     Foley Hoag LLP. (2024). FDA Finalizes Rule to Assert Authority Over Laboratory Developed Tests. Retrieved from https://www.foleyhoag.com/news-and-insights/publications/alerts-and-updates/2024/may/fda-finalizes-rule-to-assert-authority-over-laboratory-developed-tests/

3.     FDA. (2024). Labeling Requirements for In Vitro Diagnostic Devices. Retrieved from https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/labeling-laboratory-developed-tests-faqs

4.     FDA. (2024). Medical Device Regulations and Premarket Submissions. Retrieved from https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance